New nightly pill aims to tame daytime sleepiness in rare sleep disorder
NCT ID NCT06525077
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a once-nightly extended-release form of sodium oxybate (FT218) in 157 adults with idiopathic hypersomnia, a condition causing excessive daytime sleepiness despite adequate sleep. Participants were already on stable doses of stimulants or other alerting agents. The trial measured changes in sleepiness and symptom severity over about 18 weeks. The goal was to see if FT218 can safely improve wakefulness and daily function.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
sodium oxybate (extended-release oral suspension)
What this could lead to
If successful, this could provide a once-nightly treatment option to reduce excessive daytime sleepiness and improve daily functioning for people with idiopathic hypersomnia.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may cause side effects like dizziness, nausea, or sleep disruption, and not all participants may benefit.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, 28078, United States
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Alpine Clinical Research Center
Boulder, Colorado, 80301, United States
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Bogan Sleep Consultants
Columbia, South Carolina, 29201, United States
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Clinical Neurophysiology Services PC
Sterling Heights, Michigan, 48314, United States
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Clinical Research Institute
Stockbridge, Georgia, 30281, United States
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Florida Pediatric Institute
Winter Park, Florida, 32789, United States
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Tidewater Physicians Multispecialty Group (TPMG) Clinical Research
Williamsburg, Virginia, 23188, United States